Thursday, May 31, 2007

Due to overlapping clinical presentations acute coronary syndrome (ACS) and pulmonary embolism (PE) can be confused. Moreover, both can be associated with electrocardiographic manifestations (T wave abnormality), elevated troponin levels (present in 42% of patients with PE in this study), and elevated d-dimer levels.

This case report (free full text after registration) illustrates disastrous consequences of massive PE mistaken for ACS. The electrocardiogram shown in the case report displayed findings which could be attributed to either ACS or PE. And while the tracing had a few previously described “red flags” for PE the elecrocardiographic distinction between ACS and PE had not been systematically studied as far as I am aware.

That’s why this paper from the March 15 issue of the American Journal of Cardiology is important. The authors studied patients with either ACS or PE who had T wave inversion on consecutive precordial leads. Among the findings: “In patients with APE, negative T waves were commonly present in leads II, III, aVF, V1, and V2, but were less frequent in leads I, aVL, and V3 to V6” and “Negative T waves in leads III and V1 were observed in only 1% of patients with ACS compared with 88% of patients with APE”. The sensitivity for PE in patients showing negative T waves in both III and V1 must be interpreted with caution, since the study population consisted only of patients with precordial lead T wave inversion. The sensitivity of the finding among PE patients in general is low. A normal electrocardiogram does not rule out PE. Nevertheless the findings of this paper should prove useful in distinguishing between ACS and PE in patients who have precordial T wave abnormality.

The New York Personal Injury Law Blog, to which I linked earlier today, wrote a follow up post in which he reported that the hard copy of the Boston Globe story is on the front page above the fold for all of Flea’s friends, family and patients to see. A big list of links can be found there.

He provided information on two other questions: What was the timing of the take down of Flea’s blog in relation to the events at trial? Who is the guy pictured at the upper left of Flea’s blog?

As Kevin reported earlier this morning, pediatrician blogger Flea settled his medical malpractice case the morning after his blog was revealed in trial. A New York attorney reflects on what it means:

The issues I raised, in the event plaintiffs' counsel discovered his blog, ran to the risks of losing his attorney-client privilege for all such communications. If this happened, he could be cross-examined on how he was coached by his defense team to act in front of the jury and the advice they gave him. He also ran the risk of his own insurance carrier trying to disclaim coverage if it thought he was hindering the defense.

….about this New York Times article on tPA for stroke. It’s full of distortions and misstatements although it makes one interesting (and controversial) assertion, which is that defensive medicine is a significant reason for under treatment of patients:

Dr. Richard Burgess, a member of Dr. Warach’s stroke team, explained the situation: There is no particular penalty for not giving tPA. Doctors are unlikely to be sued if the patient dies or is left with brain damage that could have been avoided. But there is a penalty for giving tPA to someone who is not having a stroke. If that patient bleeds into the brain, the drug not only caused a tragic outcome but the doctor could also be sued. Few emergency room doctors want to take that chance.

Through several dramatic stroke anecdotes the piece, with little apparent regard for perspective or accuracy, paints tPA as some sort of miracle drug. Here are some of the distortions.

Doctors are therefore reluctant to give the only drug shown to make a real difference, tPA, or tissue plasminogen activator. The only drug shown to make a real difference? Wrong. Aspirin is associated with improved outcomes and reduced mortality in the first few weeks. This, in fact, is more than can be said for tPA, which does not reduce mortality.

Although tPA was shown in 1996 to save lives and prevent brain damage… Since the article contains no citations to back up its assertions I can only guess that this statement refers to the NINDS study, even though that study was published in 1995, not 1996. The study, the only large randomized trial to show benefit from tPA, showed no statistically significant reduction in mortality. The title of the NYT piece, Lost Chances for Survival, Before and After Stroke, also deceptively implies that tPA is life saving.

Concerning the evaluation of patients for tPA treatment, the article says Many hospitals say they cannot afford to have neurologists on call to diagnose strokes, and cannot afford to have M.R.I. scanners, the most accurate way to diagnose strokes, for the emergency room. Nonsense. The widely accepted guidelines for the use of tPA, which are based on clinical assessment and CT imaging, mention no role for MRI scans.

There’s more. Although the New York Times is widely regarded as a reputable source of medical news this particular NYT piece is yet another example of how scientific issues are distorted when discussed in popular media.

Monday, May 28, 2007

Dr. RW has a valid point. I am sick and tired of all this gibberish about medicine clogging up the media. What this country needs is a separation of scientific discourse (including medicine) from the public. What possible good comes from public awareness and discussion of scientific matters? We should ban any scientific thought and discourse by anyone without a Dr. before his name.

Heck, I don’t care whether you have Dr. before your name if you want to discuss science. The real points of my argument, which Greedy Trial Lawyer didn’t address, were these:

Scientific discussion was hijacked by CNN, the New York Times, activists and trial lawyers. (Do I really have to explain what’s so wrong with that?).

The “jury verdict” on Avandia was in within hours of the release of the scientifically flawed NEJM meta-analysis.

The irresponsible media hype surrounding Avandia jeopardized not only reasoned scientific discussion but also an important and much needed clinical trial whose future is now in question.

The Public Citizen Health Research Group took advantage of the Avandia controversy for a little self congratulation, saying in effect “We told you so”. But that may be a little deceptive. What they actually told us about was stuff we already knew and had addressed, principally related to the problem of fluid retention which can exacerbate heart failure, and which in no way anticipated the concerns raised by the NEJM meta-analysis.

Worse, they come just short of advising patients to unilaterally discontinue Avandia with this statement: We strongly urge patients - as we have for almost two and a half years - not to use this drug. Wouldn't it suffice to say "ask your doctor"?

Sunday, May 27, 2007

Mere moments following NEJM’s release of the Avandia meta-analysis and editorial there were millions of Google search queries for Avandia according to a recent post from Clinical Cases and Images. Malpractice attorney ads began appearing only hours later. Hype spreads more rapidly than nuanced critical analysis. So, long before defects in the paper had a chance to be exposed, the popular media, consumer activists and the trial lawyers had taken over the debate. Within hours Avandia was the new Vioxx. More recently we have learned that the ongoing prospective RECORD trial, designed to look at macrovascular outcomes in patients taking Avandia, is in jeopardy (hat tip to Kevin M.D.) due to patients dropping out as a result of the publicity. Something’s terribly wrong with this picture.

Clearly tabloid based medicine has trumped evidence based medicine and done much harm. I have repeatedly argued that discussions of science are corrupted when played out in the arena of public debate. The Avandia controversy is a case in point.

Saturday, May 26, 2007

The best regimen for VTE prophylaxis is controversial. Some recent research helps clarify but does not completely settle the controversy. This study in Thrombosis Journal evaluated outcomes in patients with a variety of medical conditions who received VTE prophylaxis with either the low molecular weight heparin (LMWH) enoxaparin versus unfractionated heparin (UH). There was a markedly reduced incidence of VTE in the enoxaparin group with no difference in adverse effects. The study received support from Aventis Pharmaceuticals, makers of enoxaparin. A potential weakness in this retrospective study is the lack of control over the doses of UH and LMWH. On the other hand it reflects real world use of the agents.

Then there was this prospective randomized open label study of enoxaparin versus UH for VTE prophylaxis in post-stroke patients presented at the American Stroke Association last February, showing a lower rate of VTE with enoxaparin and no difference in bleeding rates. This study, entitled Prevention of VTE After Acute Ischemic Stroke with Low-Molecular-Weight-Heparin Enoxaparin (PREVAIL), was also sponsored by Aventis. One weakness of this study, some might argue, is that it set up a straw man by testing enoxaparin against what some experts assume to be a less than optimal dose of UH (5000 units bid). However, this recent meta-analysis in Chest questions that assumption in that, in medical patients, the higher dose of UF, 5000 units tid, was no better than bid despite a higher bleeding rate.

Although the issue remains controversial, recent data suggest superiority of LMWH over UH for VTE prophylaxis in a variety of settings.

Thursday, May 24, 2007

Musings of a Distractible Mind shared some Thoughts on Avandia today (via Kevin M.D.) and is rightfully concerned that irresponsible popular media coverage seems to be guiding scientific discussion. In discussing some of the flaws of the meta-analysis he notes this:

We had an endocrinologist in our office a few days ago (not representing GSK) and we discussed this issue, and his comment was that Dr. Nissen is “the Michael Moore of the medical industry.” Strong words. Mr. Moore is a crusader against the big and rich for the protection of the little guy (in his opinion). The problem is (in my opinion) that Mr. Moore does not always come to conclusions based on evidence, but starts with a conclusion and finds evidence to support this. This is precisely the danger of a meta-analysis of the sort that was done in this case.

Dr Steven Haffner (University of Texas Health Science Center, San Antonio), who was involved in the ADOPT study of rosiglitazone, said the paper needed to be published, but it should have undergone a more extensive review, and there should have been a different editorial with more emphasis on the flaws of the study. “The NEJM was irresponsible to go to [Drs Bruce] Psaty and [Curt] Furberg for the editorial--they were always going to emphasize concerns about drug safety; that’s what they do," he commented.

Dr. Robert Califf of Duke University commented on the harmful effect of scientific discussions being played out in popular media:

“It would be better if we had a system of postmarketing signal detection in which signals were vetted scientifically rather than splashed over TV and newspapers. I can't help but wonder if the NEJM is functioning more like the mainstream press than a scientific journal at this point, since many potential peer reviewers seem to feel that Dr Nissen's analyses are missing key elements that could have been added."

The latest MedGenMed video editorial reminds us of the importance of the clinical pharmacist. It’s worth viewing and makes valid points. I’m wondering, though, if it’s part of a promotional campaign. It’s the third MedGenMed videoeditorial in just over a month telling us not to forget the clinical pharmacist. I think I get the message.

Wednesday, May 23, 2007

In my humble opinion a bad meta-analysis belongs at the bottom of the evidence based medicine hierarchy. The Avandia meta-analysis has been accepted uncritically by the media but how good is it, really? The Angry Pharmacist has some questions. The entire post is compelling reading, but I was most interested in the part about the conflict of interest disclosure, a point the popular media missed entirely: Dr. Nissen reports receiving research support to perform clinical trials through the Cleveland Clinic Cardiovascular Coordinating Center from Pfizer, AstraZeneca, Daiichi Sankyo, Roche, Takeda, Sanofi-Aventis, and Eli Lilly.

Nesiritide: Controversial. Large mortality and cost effectiveness trial about to begin.

CPAP, BiPAP: Now considered first line as initial short term therapy in acute cardiogenic pulmonary edema. (Invasive mechanical ventilation may be more appropriate in some patients presenting with acute myocardial infarction).

Inotropes, PDE inhibitors: Generally avoided and limited to short term palliative use. May increase mortality.

“What to do with long-term ß-blocker therapy in the setting of acute decompensated heart failure remains a clinical conundrum. Our practice is to reduce the dose proportionate to the degree of hemodynamic compromise; the ß-blocker dose may be decreased by about half in patients with evidence of hypoperfusion, and stopped in patients with frank cardiogenic shock, although there is little evidence to support this approach. Following an episode of acute decompensated heart failure, ß-blocker therapy should be titrated upward slowly.”

ER Pocketbooks is a non-anonymous blog which posts clinical images. It’s the latest subject of the recent flurry of posts which relate, in one way or another, to the hazards of blogging. The site got the attention of KNSD, channels 7/39, San Diego which ran this: A North County emergency room doctor is generating controversy by posting X-rays and pictures of patients' injuries on his Web site, NBC 7/39 medical correspondent Peggy Pico reported.

Although a hospital where the blogger works as an emergency physician was concerned about how the images were obtained the KNSD report concludes there were no HIPPA violations since the images contained no patient identifying information.

The blogging fears that have been expressed recently have been all over the map, it seems to me, without a really consistent theme. After all, the individual blog shutdowns occurred for different reasons. That makes it difficult to know just what is the lesson of Black Wednesday.

At any rate, regardless of where one weighs in on the controversy, ER Pocketbooks looks like a site worth checking out for its educational value. Here, for example, he presents a well discussed and well referenced case of an underappreciated entity: Wellens syndrome.

Monday, May 21, 2007

Today the New England Journal of Medicine released, on line ahead of print, a meta-analysis of 42 trials looking at the effect of rosiglitazone on cardiovascular outcomes. The use of rosiglitazone, compared against placebo or other regimens for type 2 diabetes, was associated with a statistically significant increase in myocardial infarction and a non-statistically significant trend toward increased cardiovascular mortality.

This finding begs the question of whether the apparent adverse effect is a class effect of thiazolidinediones (TZDs) or is unique to rosiglitazone. The meta-analysis findings are in contrast to the PROactive study of the other TZD approved in the U.S., pioglitazone, which showed improved cardiovascular outcomes. I commented on PROactive here, here and here. A new analysis of PROactive published in the Journal of the American College of Cardiology (JACC), looking at recurrent MI in the cohort of patients with previous MI (2,445, just under half of the PROactive population) showed a statistically significant reduction in the pioglitazone group. The official PROactive web page contains updates.

Psaty and Furberg commented on the meta-analysis findings in this editorial. They point out that although ongoing trials may shed favorable light on rosiglitazone, a lack of positive outcome data in the long period since approval in 1999 is concerning, and reach this sobering conclusion: “On the basis of this meta-analysis, however, the possibility of cardiovascular benefit associated with the use of rosiglitazone seems remote.”

Sunday, May 20, 2007

Panda Bear is a medical blog I discovered today, thanks to Kevin. Panda Bear seeks to challenge the politically correct dogma of an elitist medical establishment he refers to as “The Man”. His contrarian ways of looking at medicine and society are refreshing. Here’s a sampling from recent posts:

The conventional wisdom is that the American health care system is broken. This is the party line parroted by the various media organs of the dependocracy in their attempt to stampede an excitable public towards socialized medicine. Like a lot of the conventional wisdom, the idea of a broken health care system gets repeated so often that it has become a cliche, something that people spout in a self-righteous reflex. It is certainly a pleasant metaphor and an easy one for the people to get a handle on without having to think about the real complexities of delivering zero-defect medical care to a largely non-compliant public….

We pay lip service to the idea of patient-centered health care of course, and including the patient as an equal partner in medical decisions is the New Religion. In our society however, where a physician can get sued for not having written on the discharge instructions for a dead crack dealer, “Return to Emergency Department if chest pain returns,” well, there just isn’t as much equal partnering as you’d like to believe.

In fact, there’s none to speak of where it counts. Not an artery hardens or liver fails without a physician somewhere, somehow being blamed.

There are many versions of the Hippocratic Oath and it is continuously edited to suit the demands of political correctness.

…..it is not a requirement that physicians be social activists or professional busy-bodies.

Maybe a hundred years ago you could make a case for magic potions and mysterious cures from the East but today we should know better and only don’t because of a combination of scientific illiteracy and an ingrained bias against rational Western thought.

Since there is a large amount of evidence from many reports regarding an association between neurologic damage and cervical manipulation, and because there are no identifiable risk factors, anyone who receives CSMT can be at risk of neurologic damage. It is important for patients to be well informed before undergoing this kind of procedure and for physicians to recognize the early symptoms of this complication so that catastrophic consequences can be avoided.

Wednesday, May 16, 2007

Among the blogospheric reactions to the departures of Flea and Fat Doctor I found this one interesting over at Stranger than you can imagine: I think the risks are too high. I think that all of the medical bloggers are going to disappear or go private in a month or less.

Despite evidence that imipenem frequently cross reacts with penicillin and the general belief that all “penems” should be avoided in penicillin allergic patients, meropenem seldom cross reacted in this study. Nevertheless, the authors recommend skin testing before using meropenem in penicillin allergic patients.

---at the Body Heals Conference. The bio describes Adam the Dream Healer as a “distant energy healer” who “uses energy healing in a unique way to merge the auras of all participants with healing intentions. Then he uses holographic views to energetically affect through intention those present.” Before you dismiss these methods note: “We would like to impress upon everyone that what Adam does is not mystical or magical. It is all based on science.”

There’s more. Learn the secrets of youthful aging from Dr. Norm Shealy. “Those with the essential healthy attitude and lifestyle will live an average of 100 years, and the wisest will choose habits to add another 40 years.”

And if you really want to pursue wellness, get a horse! Sandra Wallin, MA, RCC, BSc, Bed introduces the Equine Apothecary.

Additional sessions cover Qi Gong, homeopathic weapons against the coming influenza pandemic, the “fluoride deception” and cancer as a “moral illness.” I don’t think I’ve seen so much woo packed into one CME activity. My head is swimming.

Monday, May 14, 2007

In a population of patients with dilated cardiomyopathy and atrial fibrillation, maintenance of sinus rhythm via ablation (mainly pulmonary vein isolation) was associated with nearly universal improvement in left ventricular systolic dysfunction with normalization in most patients. The study, recently published in the Journal of Cardiovascular Electrophysiology, adds to the growing evidence for the existence of chronic tachycardia mediated cardiomyopathy as a distinct and important clinical entity.

In this systematic review efficacy was unclear beyond 16 weeks and “aberrant medication-taking behaviors” (translate seeking, abuse) was noted in up to 24% of patients. That finding certainly differs from the current pain management dogma that “addiction is rare.”

Sunday, May 13, 2007

It’s often said that the debates over alternative medicine are pointless because there is really no alternative medicine; there’s only medicine that has been proven to work and medicine that hasn’t. At first glance the notion seems sound. Simply subject an alternative claim to scientific investigation. If it proves out it becomes mainstream, otherwise it is rejected. If only it were so simple! The reality is that little has been settled despite many years and hundreds of millions of dollars devoted to alternative medicine research. I offer examples here of why this is so.

Promoters of unscientific claims often reject ordinary scientific standards for experimental design and evidenceThe American Medical Student Association, the largest and most influential organization of medical students, promotes many unproven methods. In their web pages on integrative, complementary and alternative medicine they suggest that currently accepted scientific methods may not be optimal to study alternative medicine. Moreover, they imply that complementary and alternative medicine should be adopted now, without waiting for definitive evidence, with this statement: “For most CAM therapies, the final word is not yet in on their effectiveness. But the medical community cannot wait for the final word; they need to know what patients are using now and if it is effective. Many primary care doctors are opening clinics with CAM practitioners. These integrated medical centers provide one of the best learning tools for current physicians and may be the most efficient and effective way to blend conventional and unconventional medicine.”

Even government funded CAM research is troubled with serious methodologic flawsPerhaps the best example of such flawed design is the National Center for Complementary and Alternative Medicine’s ongoing Trial to Assess Chelation Therapy as a treatment for atherosclerosis. As I pointed out in this post, many of the study sites appear to be tainted by a lack of objectivity and dubious scientific qualifications. That lack of objectivity is especially concerning because the investigators are not securely blinded.

Research on complementary and alternative methods is conducted without regard to biologic plausibilityNumerous subjects of CAM “research” are so implausible they would require rewriting the chemistry and physics books. These include claims that a mystical force remains in water after solute is diluted out (homeopathy), imaginary claims of “energy fields” which can’t be measured or detected (various energy healing modalities) and purported energy channels that have no basis in anatomy (the meridians of acupuncture and related methods). It’s as if the NCCAM is willing to “study” any claim, no matter how preposterous, if there’s consumer interest and available funding.

Why is this problematic? Because the test of plausibility is an important safeguard, without which baseless health claims can be subject to clinical studies, occasionally passing the test of statistical significance and yielding “positive” results by chance variation. That might not be a major problem were it not for positive publication bias in quackery promoting journals which receive favorable consideration for Medline indexing, thus inflating dubious claims subjected to meta-analyses, which rely heavily on Medline searching. (See below). In consequence, woo based claims get the trappings of evidence based medicine. My principle for plausibility testing is crude but vivid: “evidence based” woo is still woo!

Government oversight is biased in favor of complementary and alternative medicineDr. Wallace Sampson, Emeritus Clinical Professor of Medicine at Stanford University, has extensively researched the procedures of journal selection by the National Library of Medicine for indexing in Medline and uncovered enormous bias in favor of CAM oriented journals which are largely promotional, uncritical and agenda driven. The whole process, it seems, is corrupted by conflicts of interest. Moreover, the FDA has a lax double standard which is favorable to the development of herbal remedies.

Evidence based medicine (EBM) has failed to remedy the many problems in CAM research. It cannot adequately address the massive agenda which drives much of the research and pays too little regard to biologic plausibility. This is due to misappropriation and misunderstanding of EBM more than any inherent failings of EBM.

Saturday, May 12, 2007

In the February issue of Mayo Clinic Proceedings is a review of case based learning resources for internists on the web. It contains a huge collection of links. It’s behind access controls now, but will be open access in August.

Not all of the sites offer CME credit, and of those which do some charge for the CME processing although the content is free.

Friday, May 11, 2007

Dr. Keith Thompson became frustrated at the false anonymous comments about himself and his colleagues. He tried to work with the site’s owners to change commenting procedures. That didn’t work, so----

"I spammed the site because I was upset with what I saw about colleagues that I knew was false and because I saw the site as being no more valid than an MSN chat room," Dr Thompson told NRM by email. "I have consistently tried to make my point that ratings or comments need to be available to registered users only...

The other thing that worries me about socialized medicine is that there is no incentive there for the best-and-the-brightest to undertake the arduous work (and heavy cost) of obtaining medical degrees, so that they can be under the power of the Government, rather than allowed to strike out on their own. Then who will be our next doctors? The second tier students? The third? Socialism too often is a showcase for mediocrity. It doesn't work. The private sector is imperfect, and there are certainly issues within our health care system that need addressing, particularly for the un-insured, but throwing us into this fresh hell is not the answer.

The McClatchy Newspapers have been doing some investigative reporting on VA health care. “The Department of Veterans Affairs has habitually exaggerated the record of its medical system, inflating its achievements in ways that make it appear more successful than it is, a McClatchy Newspapers study shows.” The report cites doctoring of appointment records to show shorter wait times and more.

On May 3 Scientific American posted an article about the paper which was predictably uncritical and largely unrevealing until the last paragraph:

This research may already be having an impact on policy debate: According to Woolhandler, Ohio democratic congressman and presidential candidate Dennis Kucinich has plans to circulate the results of this study to Congress. Woolhandler herself would like to see this study play a part in a slightly different debate—one over whether it it [sic] is better to be sick and insured in the U.S. or in Canada. "I'd like to see politicians giving up on this mythology that the quality of care for sick people in the U.S. is unique."

Woolhandler, of course, is one of the authors of the Open Medicine paper and, like the other authors I profiled here, an admirer of Canada’s health care system and an activist for adoption of a similar system in the U.S.

Dennis Kucinich is a Democratic presidential candidate. Moreover he’s a supporter of single payer health care and the co-author of HR 676, a plan for a “universal, single payer, not for profit health care system”. In principle Kucinich’s proposal is similar to Woolhandler’s and not unlike Canada’s system.

So, let’s look at a possible time line. The Scientific American article was posted May 3. Since it’s an on line article and not a post on their blog the editorial process between submission and posting likely took several days. We must then ask how many days before submission did the interview with Woolhandler take place and, how long before the interview did she know of Kucinich’s plans to distribute the study results to congress? Since Open Medicine was not launched until April 18 that didn’t give Kucinich much time to find out about the paper. How could he have searched for it? Open Medicine isn’t listed in PubMed yet. Did he search the blogs? With his busy campaign schedule and congressional duties would he have had time to do that?

Does Woolhandler have any association with Kucinich? What’s the nature of any conversations they may have had? And dare we ask: Did Kucinich learn about the paper with the help of one of its authors? The big question, and one I raised in my previous post, is whether or not this paper was submitted with political intent. The Scientific American piece lends further credence to that question.

Maybe so according to a paper in PLoS Medicine: Lethal Injection for Execution: Chemical Asphyxiation? The authors looked at execution records from 2 states, examined eyewitness accounts of execution by lethal injection and examined the relevant pharmacology. They write:

We were able to analyze only a limited number of executions. However, our findings suggest that current lethal injection protocols may not reliably effect death through the mechanisms intended, indicating a failure of design and implementation. If thiopental and potassium chloride fail to cause anesthesia and cardiac arrest, potentially aware inmates could die through pancuronium-induced asphyxiation. Thus the conventional view of lethal injection leading to an invariably peaceful and painless death is questionable.

In other words the effect of thiopental as it is used in execution protocols may not be strong or long lasting enough to eliminate awareness of the pancuronium-induced respiratory paralysis or the intense pain resulting from injection of concentrated potassium chloride.

The article also cites eyewitness accounts suggesting inmates’ suffering and points out that execution by lethal injection doesn’t have nearly the research underpinning or ethical oversight that is applied to animal euthanasia. This paper may result in increased pressure for states to open their execution records and may be a stimulus for legal challenges against execution by lethal injection.

Now for some personal disclosures and reflections. I oppose capital punishment. I also, as regular readers know, believe that scientific discussions can be corrupted when mixed with political debate. When such discussions overlap, as they inevitably must, safeguards are necessary. First, while science can legitimately inform political discussions (in the case of lethal injection, the authors clearly show us that we had better understand a little pharmacology before we can argue about whether it’s humane) it should not be the other way around. Second, appropriate disclosure of significant political affiliations or leanings is essential. To the credit of PloS Medicine appropriate disclosure seems to have been made. We are informed that one of the authors practices capital defense, another has been a paid expert in death penalty litigation and all the editors at PLoS Medicine oppose the death penalty. Other journals should take note.

Wednesday, May 09, 2007

The MTHFR 677C-T polymorphism increases homocysteine levels. Meta-analyses have demonstrated a weak association of the 677TT genotype with risk of VTE, although these data may be troubled by publication bias. In this large population-based case-control study the genotype was not associated with increased risk of recurrence. MTHFR gene testing is not recommended although homocysteine testing is reasonable.

Mayo Clinic investigators surveyed attendees of 4 of their own Internal Medicine CME programs, 2 of which received pharmaceutical industry support and two of which did not. Respondents’ attitudes regarding industry sponsorship were evaluated. The results were not surprising. Overall, a majority (about 58%) had no general preference as to whether an event received sponsorship or not. On the other hand, a similar majority (62%) believed that a CME program should accept support it would reduce the cost for attendees.

A synthesis of current recommendations regarding industry CME support by the AMA, ACP and ACCME was given by the authors, who believe that adherence to such guidelines will substantially reduce inappropriate industry influence and bias. In effect these recommendations call for unrestricted grants, conflict of interest disclosure by speakers, no industry role in determining content, support given to program organizers rather than the participants and safeguards against bias. I agree.

Three patients recently died shortly after receiving intravenous injections of colchicine provided by an integrative medicine clinic in Portland Oregon. It was discovered that the batch of colchicine, obtained from ApothéCure Inc., was 10 times as potent as labeled. Two of the deaths have been officially determined to be due to the faulty preparation while the third is under investigation. Colchicine was being used for the off label indication of chronic neck and back pain.

It's amazing how people are willing to believe the worst about Big Pharma (which is guilty of some amazing abuses, to be sure) but they are also willing to give un-Big-Pharma a free pass on what they are doing and selling and how much profit they are making.

ApothéCure, it seems, has been investigated before. Dr. Geoffrey Wiss, a Portland emergency physician, was a partner in the integrative medicine clinic and noted that although colchicine was available from manufacturers the clinic ordered it from ApothéCure because it was less expensive. It is unclear who prescribed the colchicine. Although the patients were under the care of naturopaths, Wiss and other M.D.s collaborate in the clinic. Naturopathic physicians have prescriptive privileges in Oregon. Dr. Wiss, profiled here, joined the clinic in 2005 to learn about alternative medicine by working with naturopathic physicians. He was credited with recognizing the pattern of deaths and alerting authorities.

These deaths raise many questions. Were naturopaths, generally loathe to use prescription drugs and whose mantra is first do no harm, involved in the administration of the highly toxic drug colchicine? Well, I guess it is “natural”. After all, it’s an alkaloid.

Author Charles Durbin, M.D. notes the unacceptably high mortality in sepsis, the potential for multiple evidence based modalities to impact this mortality and the universal gap between publication of evidence and clinical implementation. The Surviving Sepsis Campaign (SSC) was conceived to try and close this gap. The task, unfortunately, took extensive resources, resources not available from public funding. Although Eli Lilly supported the logistics of the campaign the company had no role in the development of the guidelines.

The Society of Critical Care Medicine (SCCM) undertook the process of sepsis guideline revision last year without industry sponsorship in order to avoid unwarranted criticism. Durbin hints that the revised guidelines and bundles will not substantially change, thus supporting the work of the 2004 authors.

He concludes:

Viewed pragmatically, the SSC under the stewardship of respected medical societies is a fundamentally sound and promising endeavor to improve patient care. The premises of the Campaign remain vital: 1) the mortality rate for severe sepsis is unacceptably high; 2) practice guidelines, developed through a rigorous evidence-based review of the literature, must be translated into practice; and 3) research questions about the efficacy of a bundle approach in severe sepsis and the differential impact of combining sepsis therapies must be answered. SCCM strongly supports the call for the creation of public funding mechanisms to accomplish translational research. In the meantime, the Campaign will press forward to reduce mortality attributable to severe sepsis with the resources available.

The more vocal guideline critics seem mainly to be screaming about the role of industry, offering little in the way of constructive criticism. One wonders whether they’re concerned with anything more than industry bashing. If they want to help doctors take better care of patients with sepsis they should discuss the evidence on its own merits. If the guidelines are hopelessly flawed they should help develop better ones. Everyone will get along better and patients will benefit.

The comment thread in Aggravated DocSurg’s recent hospitalist rant pointed me to The Hospitalist Blog, written by IPC hospitalist company leader Adam Singer, M.D. This blog has been up and running about a year, but is new to me. I shall browse with interest.

Monday, May 07, 2007

This is long overdue. I haven’t had nearly enough time to properly tend to this blog. Check out the new links. Listing on this blogroll does not imply agreement or endorsement. What it does mean is that these blogs post content of interest to me often enough to warrant inclusion here. More to come as time permits.

There is no more stinging indictment of the hospitalist phenomenon than this: The patients hate it. They want to be cared for by their own doctors. When will the peeps speak up and tell the hospitals they hate the hospitalists? If the powers that be won't listen to the fleas, perhaps they'll listen to the customers.

I must respectfully question that assertion and again point out that a collection of anecdotes does not equal evidence. The best evidence that I’m aware of comes from this systematic review of hospitalist outcomes. Of the 19 papers in the review 4 reported on patient satisfaction. In all 4 of those studies no difference in patient satisfaction was found between the hospitalist model and the traditional care model. From the patient’s point of view the disadvantage of hospitalist care, discontinuity, may be counterbalanced by the fact that the hospitalist is “there” all day, can make frequent re-visits when necessary and may be more accessible to families.

----is one of several conflict of interest disclosures given by Thomas P. Stossel, a participant in Medical Progress Today’s conflict of interest symposium. You can view a text only or slide version of his presentation. Although not against reasonable safeguards he effectively shatters some of the simplistic and extreme positions now being put forth concerning the interaction between medicine and industry.

Appropriate and reasonable concern about the influence of industry on science has swung to an unhealthy extreme. He notes “In the past we named sponsors of our research and education efforts to honor them. Now, all disclaimers to the contrary, we are forced to itemize sponsors so that the beholder can discount our words and our work and to satisfy a prurient interest in our earnings.”

Though Stossel isn’t advocating for non-disclosure he notes adverse consequences of our obsession with industry connections: “Nothing better illustrates how what we disclose demeans us than the call to have only the second best and the not so bright, persons free from all commercial interests, serve in advisory roles.” Is there support for this implication that exclusion of experts with industry connections leaves us with “second best and not so bright”? It was certainly true in the experience of New England Journal editors in 2002 who found they had to relax their policy banning commercial interests in order to find qualified authors for their drug therapy series.

Stossel addresses the selective outrage about conflicts of interest with this: “Interestingly, these authorities exempt the principal source of money exchange in medicine—clinical practice—from the segregation of production and promotion, even though promotion of clinical services is routine.”

Sunday, May 06, 2007

The 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiac Care have incorporated new recommendations for the application of therapeutic hypothermia in the post resuscitation period. External cooling applied to comatose patients upon return of spontaneous circulation (ROSC) who are hemodynamically stable results in increased survival and better neurologic outcomes. Out of hospital cardiac arrest in which the initial rhythm was VF carries a Class IIa recommendation. In hospital cardiac arrest and out of hospital non VF arrest carry a IIb recommendation.

There are details to attend to in real world implementation of the recommendations. Patient selection is difficult, and many patients will not be candidates. This concise review in CMAJ covers some of the practical aspects such as cooling methods, temperature goals, patient selection and complications.

Friday, May 04, 2007

U.S. medical schools are more than glad to help. “Ayurveda is set to make a landmark entry into mainstream U.S. medical education” according to this report.

The course is the result of four years' hard work by Riverdale, Md.-based urologist Navin Shah, who took on the challenge of bringing Ayurveda to mainstream U.S. medical education after a request from erstwhile Indian Prime Minister Atal Behari Vajpayee, he told India-West."Vajpayee wanted me to propagate Ayurveda," he said. "I told him the best way is to go through the medical schools, because we want to enter through the main door of the mainstream, which is (the) medicalschool."

The med schools came through. Several are preparing to offer courses to medical students and house officers. Dr. Shah even foresees Ayurveda achieving subspecialty status in the field of Internal Medicine.

Wednesday, May 02, 2007

It’s all a matter of what works best for you and your patients. Although physicians who juggle the responsibilities of office and hospital practice seem to be a dying breed there are many who do it well.

The January 19 issue of Medical Economics offers a point-counterpoint.

Tuesday, May 01, 2007

This is according to a report on a Pseudomonas aeruginosa outbreak that took place on a neonatal ward in a Montreal hospital in 2004-2005. After disinfection efforts failed to stem the outbreak the ward was closed. Pseudomonas, which likes stagnant water, was found, according to the investigation, festering in the sinks on the wards because the sinks did not drain properly.

There’s a pattern emerging. Outmoded facilities constitute an infection control problem. Canada faced a similar issue with the new highly virulent Clostridium difficile strain which broke out in Quebec hospitals. A study in CMAJ described the outbreak and highlighted the high attributable mortality. That paper concluded: The lack of investment in our hospitals infrastructure over several decades, with shared bathrooms being the rule rather than the exception, may have facilitated the transmission of this spore-forming pathogen, which can survive on environmental surfaces for months. Providing modern medical care within hospitals built a century ago is no longer acceptable.

An accompanying editorial noted we need to begin long-neglected upgrades in hospitals infrastructure, as there is a lag of almost a decade between the intention to build and the completion of projects and cited the related observation that the risk of nosocomial acquisition of methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci and C. difficile was reduced 4-fold after the medical teaching unit at the Foothills Medical Centre in Calgary moved from a 5:1 to a 1:1 bed-toilet ratio.